Reported Sep 23, 2015 · Terminated
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit…
Pointe Scientific, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pointe Scientific, Inc. · 5449 Research Dr · Canton, MI · 48188-2261
Is this the product you have?
- Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40
- ml of R1 and 3x14 ml of R2 KitsHDPE plastic bottle, PP plastic caps
- BulkPE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only
- Lot codes and dates
- Catalog numbers
H7545-R112-H7545-162H7545-1000
- HDL600 Lot number430402
- Catalog numbers
- Amount recalled
- H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; HDL600, 6 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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